Durvalumab

Therapeutic Durvalumab antibody from the original Imfinzi® commercial drug

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PD-L1
Monoclonal Antibody
Imfinzi®
50 mg/mL
40 µL
2 mg
2-8°C / -80°C
10/2021
236,00 
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Imfinzi® / Durvalumab Reference Product

Drug nameImfinzi®
INNDurvalumab
API typeDurvalumab is a human monoclonal IgG1κ antibody
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies
ATC code
L01XC28
Target of antibody
PD-L1
Synonyms: CD274, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, A530045L16Rik, B7h1, Pdcd1l1,
Pdcd1lg1, Pdl1, RGD1566211
General functionDurvalumab, is a monoclonal antibody, a type of protein designed to recognize and attach to a protein called ‘programmed death-ligand 1’ (PD-L1), which is present on the surface of many cancer cells, produced in Chinese hamster Ovary (CHO) cells.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system. PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and 13 tumour-associated immune cells in the tumour microenvironment. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation and cytokine production.
Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC). Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.
Original license holder
AstraZeneca
Marketing authorisation numbers
EU/1/18/1322/002
Marketing authorisation holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Name of the manufacturer of the biological active substance
AstraZeneca Pharmaceuticals LP
Frederick Manufacturing Center (FMC)
633 Research Court
Frederick, Maryland 21703 United States
Name and address of the manufacturer(s) responsible for batch releaseMedImmune UK Ltd
6 Renaissance Way
Liverpool,
L24 9JW
United Kingdom

alternatively:

MedImmune Pharma B.V.
Lagelandseweg 78
6545CG Nijmegen,
Netherlands
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
Histidine
Histidine hydrochloride monohydrate
Trehalose dihydrate
Polysorbate 80
Evidentic Support
+49 (0) 30 959 99 8831

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